{"id":1565,"date":"2025-02-12T15:47:55","date_gmt":"2025-02-12T15:47:55","guid":{"rendered":"https:\/\/link2america.us\/?p=1565"},"modified":"2026-05-07T16:12:10","modified_gmt":"2026-05-07T16:12:10","slug":"quick-guide-to-mocra-compliance-for-cosmetics-in-the-united-states","status":"publish","type":"post","link":"https:\/\/link2america.us\/en\/guida-rapida-alla-conformita-mocra-per-i-cosmetici-negli-stati-uniti\/","title":{"rendered":"Quick Guide to MoCRA Compliance for Cosmetics in the United States"},"content":{"rendered":"<p class=\"wp-block-paragraph\">He&nbsp;<strong>Modernization of Cosmetics Regulation Act (MoCRA)<\/strong>&nbsp;represents one of the most significant regulatory reforms in the US cosmetic sector. With new provisions regarding&nbsp;<strong>registration, labeling, adverse event reporting and inspections<\/strong>, the MoCRA imposes stricter compliance standards for companies operating in the US market. This guide offers a detailed in-depth look at the main requirements and their respective deadlines.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">\ud83d\udcc5&nbsp;<strong>Key Dates and Main Obligations<\/strong><\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>July 1, 2024<\/strong>Deadline for registration of cosmetic facilities and product listing with the FDA.<\/li>\n\n\n\n<li><strong>December 29, 2024<\/strong>Requirement to update labels with contact information for reporting adverse events.<\/li>\n\n\n\n<li><strong>December 29, 2025<\/strong>FDA publication of the safety report on PFAS in cosmetics.<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">\ud83c\udfed&nbsp;<strong>Facility Registration and Product Listing<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Companies that manufacture or process cosmetics destined for the United States must:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Get a&nbsp;<strong>Facility Establishment Identifier (FEI)<\/strong>&nbsp;from the FDA.<\/li>\n\n\n\n<li>Register the plant every two years.<\/li>\n\n\n\n<li>Submit an updated list of marketed cosmetic products to the FDA, specifying the ingredients contained.<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">\u26a0\ufe0f&nbsp;<strong>Adverse Events and FDA Reporting<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Starting December 29, 2023, companies must report to the FDA any&nbsp;<strong>serious adverse event<\/strong>&nbsp;within 15 working days using the form&nbsp;<strong>MedWatch 3500<\/strong>. The definition of \u201cserious adverse event\u201d includes:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Death, life-threatening danger, or hospital admission.<\/li>\n\n\n\n<li>Persistent disability or congenital anomalies.<\/li>\n\n\n\n<li>Severe persistent skin rashes and significant hair loss.<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">\ud83c\udff7\ufe0f&nbsp;<strong>New Labeling Requirements<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">From December 29, 2024, cosmetic labels must include:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Electronic contact information<\/strong>&nbsp;(URL or QR code) for reporting adverse events.<\/li>\n\n\n\n<li><strong>Declaration of identity<\/strong>&nbsp;of the product and net quantity of the contents.<\/li>\n\n\n\n<li><strong>List of ingredients in descending order of weight<\/strong>&nbsp;(INCI names and colorants without CI code).<\/li>\n\n\n\n<li><strong>Warnings and instructions<\/strong>&nbsp;for safe use.<\/li>\n\n\n\n<li><strong>Specific wording<\/strong>&nbsp;for professional use products.<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">\ud83c\udfdb\ufe0f&nbsp;<strong>New FDA Authorities<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">MoCRA has expanded the FDA's authority, which can now:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Conduct inspections<\/strong>&nbsp;on the facilities and access company records.<\/li>\n\n\n\n<li><strong>Mandatory recalls<\/strong>&nbsp;of non-conforming products.<\/li>\n\n\n\n<li><strong>Issue Warning Letters and Import Alerts<\/strong>, blocking the distribution and importation of unregulated products.<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">\ud83c\udf0d&nbsp;<strong>Role of the US Agent for Non-US Companies<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Foreign companies exporting cosmetics to the United States must appoint a&nbsp;<strong>US Agent<\/strong>, which will act as an intermediary with the FDA for communications and inspections.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">\ud83c\udfe2&nbsp;<strong>Small Business Exemptions<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Companies with a turnover of less than&nbsp;<strong>$1 million annually<\/strong>&nbsp;they can benefit from certain exemptions, but they must still ensure the safety and compliance of the products.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">\ud83d\udcd6&nbsp;<strong>Frequently Asked Questions (FAQ)<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">\ud83d\udd39&nbsp;<strong>Which companies must register with the FDA?<\/strong><br>All companies that manufacture, package, or distribute cosmetics intended for the US market.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\ud83d\udd39&nbsp;<strong>How is the registration of a cosmetic facility carried out?<\/strong><br>Companies must obtain an FEI Number and complete registration on the FDA platform.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\ud83d\udd39&nbsp;<strong>What is the difference between an adverse event and a serious adverse event?<\/strong><br>A serious adverse event includes permanent damage, hospitalization, or life-threatening conditions, while a minor adverse event might be temporary irritation.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\ud83d\udd39&nbsp;<strong>What information must be included on the label of a cosmetic product?<\/strong><br>Product name, net quantity, ingredient list, manufacturer, warnings and claims.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\ud83d\udd39&nbsp;<strong>Can cosmetic products contain pharmaceutical ingredients?<\/strong><br>No, if a product contains active ingredients that modify the biological function of the skin, it could be classified as an OTC drug.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\ud83d\udd39&nbsp;<strong>What happens if a product does not comply with MoCRA?<\/strong><br>It may be subject to recalls, customs holds, and FDA penalties.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\ud83d\udd39&nbsp;<strong>Is there a transition period to comply with MoCRA?<\/strong><br>Companies must comply by the established dates, without grace periods.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">\ud83d\udcda&nbsp;<strong>Glossary of Terms<\/strong>&nbsp;(in alphabetical order)<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Adulteration<\/strong>Contamination or presence of unsafe ingredients in a product.<\/li>\n\n\n\n<li><strong>Claim<\/strong>Claim about a cosmetic product property.<\/li>\n\n\n\n<li><strong>Facility Establishment Identifier (FEI)<\/strong>Unique facility identifier assigned by the FDA.<\/li>\n\n\n\n<li><strong>FDA (Food and Drug Administration)<\/strong>US regulatory agency for drugs, cosmetics, and other products.<\/li>\n\n\n\n<li><strong>Good Manufacturing Practices (GMP)<\/strong>Good manufacturing practices to ensure the quality of cosmetics.<\/li>\n\n\n\n<li><strong>Import Alert<\/strong>FDA notification blocking the import of non-compliant products.<\/li>\n\n\n\n<li><strong>INCI (International Nomenclature of Cosmetic Ingredients)<\/strong>Cosmetic ingredient naming system.<\/li>\n\n\n\n<li><strong>Labeling Compliance<\/strong>Compliance of labels with FDA regulations.<\/li>\n\n\n\n<li><strong>MedWatch 3500<\/strong>Serious adverse event reporting form.<\/li>\n\n\n\n<li><strong>Misbranding<\/strong>Mislabeling or misleading labeling of a product.<\/li>\n\n\n\n<li><strong>MoCRA (Modernization of Cosmetics Regulation Act)<\/strong>US regulations governing the cosmetic industry.<\/li>\n\n\n\n<li><strong>Product Listing<\/strong>Cosmetic product registration with the FDA.<\/li>\n\n\n\n<li><strong>Responsible Person<\/strong>Legal entity responsible for product compliance.<\/li>\n\n\n\n<li><strong>Small Business Exemption<\/strong>Exemptions for companies with revenues of less than 1 million dollars.<\/li>\n\n\n\n<li><strong>US Agent<\/strong>Intermediary between non-US companies and the FDA.<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">\ud83d\udccc\u00a0<strong>For further details and support, contact us. , <a href=\"https:\/\/link2america.us\/en\/used-makeup\/\">CLICKING HERE <\/a><\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">#MoCRA #FDA #Cosmetics #Regulation #Trade in the U.S.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><\/p>","protected":false},"excerpt":{"rendered":"<p>Il&nbsp;Modernization of Cosmetics Regulation Act (MoCRA)&nbsp;rappresenta una delle pi\u00f9 significative riforme normative nel settore cosmetico statunitense. Con nuove disposizioni in materia di&nbsp;registrazione, etichettatura, segnalazione di eventi avversi e ispezioni, il MoCRA impone standard di conformit\u00e0 pi\u00f9 rigorosi per le aziende che operano sul mercato USA. Questa guida offre un approfondimento dettagliato sui principali requisiti e [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":1572,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[3,1],"tags":[],"class_list":["post-1565","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-news","category-uncategorized"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.5 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Guida Rapida alla Conformit\u00e0 MoCRA per i Cosmetici negli Stati Uniti - Link2America Consulenti Mercati USA e LATAM<\/title>\n<meta name=\"description\" content=\"&quot;Scopri le nuove regole MoCRA per l&#039;importazione di cosmetici negli USA. Obblighi, scadenze e conformit\u00e0 FDA: tutto ci\u00f2 che le aziende devono sapere per evitare blocchi e sanzioni. 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